Cell-free Fetal DNA Circulating in the Maternal Plasma as a Marker for Morbidly Adherent Placenta

Placenta Accreta Clinical Trial

— DNA-Accreta  

Official title:

Cell-free Fetal DNA Circulating in the Maternal Plasma as a Marker for Morbidly Adherent Placenta in a High Risk Population

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02784886
• Other study ID #: DC-2011-1467
• Status: Active, not recruiting
• Phase: N/A
• First received: May 19, 2016
• Last updated: May 24, 2016
• Start date: November 2013
• Est. completion date: November 2016

Study information

• Verified date: May 2016
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine whether, in a high risk population (placenta praevia and previous caesarean or prenatal suspicion of morbidly adherent placenta (MAP)), the concentration of cell-free fetal DNA circulating in the maternal plasma is significantly increased in the subgroup of morbidly adherent placenta (MAP) cases , in order to determine if the dosage of cell-free fetal DNA circulating in the maternal plasma may be a useful biological tool to detect MAP, alone or in addition to the imagery findings (ultrasonography and RMI).

Description:

Background: Morbidly adherent placenta (MAP) is a life-threatening condition characterized by placental villi being abnormally adherent to the myometrium. Prenatal identification of MAP is essential to anticipate the risk and plan optimal delivery conditions for these women while this is associated to a maternal outcome improvement. Prenatal identification based on Doppler ultrasound and/or MRI is associated with high rates of false-positive or false-negative findings responsible for adverse effects. Some cases reports have suggested that the concentration of cell-free fetal DNA circulating in the maternal plasma is significantly increased in a context of morbidly adherent placenta (MAP).

Objective: The primary objective is to determine whether the concentration of cell-free fetal DNA circulating in the maternal plasma is significantly increased in women with morbidly adherent placenta (MAP) compared to women with placenta praevia and previous caesarean. Secondary objectives are to determine whether cell-free fetal DNA circulating in the maternal plasma is a useful biological tool to detect MAP, alone or in addition to the imagery findings (ultrasonography and RMI), in a high risk population (placenta praevia and previous caesarean or only prenatal suspicion of MAP).

Design: Prospective observational study of pregnant women with placenta praevia and previous cesaeran or with prenatal suspicion of placenta accreta, conducted in 5 centers.

Methods: We expect to include 83 women at risk of MAP in two years, of whom approximately 17 (20%) will have a MAP.

Main outcome measures: The primary outcome measure is concentration of cell-free fetal DNA circulating in maternal plasma.

Conclusion: This study will be the first prospective study to include women at risk of placenta accreta and to investigate whether the concentration of cell-free fetal DNA circulating in maternal plasma is increased in MAP women and whether it is a useful biological marker to detect prenatally MAP in a high risk population.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 63
• Est. completion date: November 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Every woman:

• delivering in one of the 5 maternity units that participate to a Population-based prospective observational study of pregnant women with a placenta praevia and previous cesarean or with prenatal suspicion of accreta (PACCRETA) .

• With a placenta praevia and at least one previous cesarean delivery or having a prenatal suspicion of placenta accreta

• aged 18 or more

Exclusion Criteria:

Every woman:

• not understanding French.

• refusing to participate in the study

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Morbidly Adherent Placenta
• Placenta Accreta
• Placenta Increta
• Placenta Percreta

Intervention

Biological:
• Women at high risk of MAP
Blood sample

Locations

Country	Name	City	State
France	Angers University Hospita	Angers

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Angers	Assistance Publique - Hôpitaux de Paris, Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

References & Publications (4)

Jimbo M, Sekizawa A, Sugito Y, Matsuoka R, Ichizuka K, Saito H, Okai T. Placenta increta: Postpartum monitoring of plasma cell-free fetal DNA. Clin Chem. 2003 Sep;49(9):1540-1. — View Citation

Kayem G, Deneux-Tharaux C, Sentilhes L; PACCRETA group. PACCRETA: clinical situations at high risk of placenta ACCRETA/percreta: impact of diagnostic methods and management on maternal morbidity. Acta Obstet Gynecol Scand. 2013 Apr;92(4):476-82. doi: 10.1111/aogs.12078. Epub 2013 Feb 15. — View Citation

Sekizawa A, Jimbo M, Saito H, Iwasaki M, Sugito Y, Yukimoto Y, Otsuka J, Okai T. Increased cell-free fetal DNA in plasma of two women with invasive placenta. Clin Chem. 2002 Feb;48(2):353-4. — View Citation

Sentilhes L, Goffinet F, Kayem G. Management of placenta accreta. Acta Obstet Gynecol Scand. 2013 Oct;92(10):1125-34. doi: 10.1111/aogs.12222. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of cell-free fetal DNA circulating in the maternal plasma		from 24 weeks gestation to delivery	No
Secondary	Sensitivity of the concentration of cell-free fetal DNA		from 24 weeks gestation to delivery	No
Secondary	Specificity of the concentration of cell-free fetal DNA		from 24 weeks gestation to delivery	No
Secondary	Positive predictive value of concentration of cell-free fetal DNA		from 24 weeks gestation to delivery	No
Secondary	Negative predictive value of the concentration of cell-free fetal DNA		from 24 weeks gestation to delivery	No
Secondary	Sensitivity, specificity, positive predictive value (PPV) and negative (NPV) of the concentration of cell-free fetal DNA in association with clinical criteria ( risk factors for MAP)		from 24 weeks gestation to delivery	No
Secondary	Sensitivity, specificity, positive predictive value (PPV) and negative (NPV) of concentration of cell-free fetal DNA in association with imaging criteria magnetic resonance		from 24 weeks gestation to delivery	No
Secondary	Sensitivity, specificity, positive predictive value (PPV) and negative (NPV) of the concentration of cell-free fetal DNA and clinical criteria in association with clinical criteria, sonographic criteria and with magnetic resonance imaging criteria		from 24 weeks gestation to delivery	No